- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04852185
Evaluation of Typhoid Conjugate Vaccine Effectiveness in Ghana (TyVEGHA)
March 6, 2024 updated by: International Vaccine Institute
A Cluster-randomised Controlled Phase IV Trial Assessing the Impact of a Vi-Polysaccharide Conjugate Vaccine in Preventing Typhoid Infection in Asante Akim, Ghana (TyVEGHA)
A cluster-randomised controlled Phase IV trial (cRCT) assessing the impact of a Vi-Polysaccharide conjugate vaccine in preventing typhoid infection in Asante Akim, Ghana (TyVEGHA) with a primary endpoint of determining the total protection conferred by single-dose vaccination with Vi-TT against blood culture-confirmed symptomatic S. Typhi infection in the intervention vaccine clusters, compared with the control vaccine clusters.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Typhoid fever remains a significant health problem in sub-Saharan Africa, with incidence rates >100 cases per 100,000 person-years of observation.
Despite the prequalification of safe and effective typhoid conjugate vaccines (TCV), the uptake of these vaccines in African countries has remained low.
Real-life effectiveness data, which inform public health programs on the impact of TCVs in reducing typhoid-related mortality and morbidity, are critical to enhancing the introduction of TCVs in high-burden settings.
Here we describe a cluster-randomized trial to investigate population-level protection of TCV against blood culture-confirmed typhoid fever.
A total of 80 geographically distinct clusters have been delineated within the Agogo district of the Asante Akim region in Ghana.
Clusters will be randomized to the intervention arm receiving TCV or a control arm receiving the meningococcal A conjugate vaccine.
The primary study endpoint is the overall protection of TCV against blood culture-confirmed typhoid fever.
Total, direct, and indirect protection will be measured as secondary outcomes.
Blood culture-based enhanced surveillance will enable the estimation of incidence rates in the intervention and control clusters.
Evaluation of the real-world impact of TCVs will improve uptake of prequalified/licensed safe and effective typhoid vaccines in public health programs of high burden settings.
Study Type
Interventional
Enrollment (Estimated)
23000
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Birkneh T Tadesse, PhD
- Phone Number: +821098041348
- Email: birkneh.tadesse@ivi.int
Study Contact Backup
- Name: Thaint Thaint Thwe, MBBS, MSc.
- Phone Number: +821037907535
- Email: ThaintThaint.Thwe@ivi.int
Study Locations
-
-
Ashanti
-
Kumasi, Ashanti, Ghana, PMB
- Recruiting
- Kwame Nkrumah University of Science and Technology
-
Contact:
- Ellis Owusu Dabo, PhD
- Phone Number: +233201964425
- Email: owusudabo@yahoo.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 13 years (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet the following criteria:
- Healthy participants aged 9 months to <16 years (i.e., ≤15 years and 364 days) of age at the time of vaccination
- Participants/Parents/legally authorized representative (LAR) who have voluntarily given informed assent (sought from participants aged 12 years to <16 years) and informed consent
- Participants/Parents/LAR living within study target area at the time of vaccination and willing to follow the study procedures and be available for the entire duration of the study
Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study:
- Known allergy to any vaccine component
- Self-reported ongoing acute and/or chronic illness
- Any self-reported coagulopathies
- Any medical or social compelling reasons in the judgment of a clinical physician
- Self-reported pregnancy/Positive urine pregnancy test or lactating
- Previous typhoid vaccination in the last 5 years (proven by the presentation of a vaccine card or self-reporting).
Temporary exclusion criteria
- Self-reported fever (elevated tympanic (≥38°C) or axillary temperature (≥37.5°C)) within 24 hours of vaccination
- Self-reported use of antipyretics within 4hours prior to vaccination
- Any other vaccination during the last 4 weeks (proven by the presentation of a vaccine card or self-reporting)
- Girls ≥11 years of age with self-reported irregular menstruation or who do not know their last menstruation date
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vi-TT Arm
A single dose of Vi-TT to children 9 months to 15 years of age.
|
Single-dose V-TT administered to children and adolescents between the ages of 9 months to 15 years.
|
Active Comparator: MCV-A arm
A single dose of MCV-A vaccine to the comparator group.
|
Single-dose of MCV-A vaccine (a meningococcal vaccine)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Protection
Time Frame: 3 years
|
The incidence of blood culture-confirmed symptomatic TF in all vaccine recipients of the intervention clusters, compared with control clusters.
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety Assessment
Time Frame: 3 years
|
1) Proportion of adverse events in participants receiving Vi-TT compared with MCV-A, measured by:
|
3 years
|
Overall protection
Time Frame: 3 years
|
The incidence of blood culture-confirmed symptomatic TF in all residents of the intervention clusters compared with that in all residents of control clusters
|
3 years
|
Total protection against severe typhoid.
Time Frame: 3 years
|
The incidence of severe TF in vaccinated individuals in intervention clusters compared to control clusters
|
3 years
|
Total protection against clinical typhoid.
Time Frame: 3 years
|
The incidence of clinical typhoid fever cases, defined as persistent fever (tympanic (≥38.0℃) or axillary temperature (≥37.5℃) or reported fever for ≥3 consecutive days) with abdominal complaints at a study surveillance site in vaccinated individuals in intervention clusters compared to control clusters.
|
3 years
|
Overall protection against clinical typhoid.
Time Frame: 3 years
|
The incidence of clinical typhoid fever cases presenting at a study surveillance site among all residents of the Vi-TT clusters compared to the control vaccine clusters.
|
3 years
|
Indirect Protection aganist Blood Culture Confirmed Typhoid.
Time Frame: 3 years
|
The incidence of blood culture-confirmed symptomatic TF in non-vaccinees of the intervention clusters compared with control clusters.
|
3 years
|
Seroconversion rates
Time Frame: 3 years
|
The seroconversion rates as measured by enzyme linked immunosorbent assay (anti-Vi IgM and IgG) for S. Typhi and iNTS at defined time points in a age-stratified subset of intervention and control vaccinees.
|
3 years
|
Geometric mean titers
Time Frame: 3 years
|
The antibody concentration as measured by enzyme linked immunosorbent assay (anti-Vi IgM and IgG) for S. Typhi and iNTS at defined time points in a age-stratified subset of intervention and control vaccinees.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Florian Marks, PhD, University of Cambridge
- Principal Investigator: Ellis Owusu Dabo, PhD, Kwame Nkrumah University of Science and Technology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 24, 2021
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
March 17, 2021
First Submitted That Met QC Criteria
April 15, 2021
First Posted (Actual)
April 21, 2021
Study Record Updates
Last Update Posted (Actual)
March 8, 2024
Last Update Submitted That Met QC Criteria
March 6, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TyVEGHA2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Sharing can be considered on a case-by-case basis considering the intended use and impact.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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